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Implant Stability and Clinical Outcome between Implant Placement Using Internal Sinus Floor Elevation with Alloplastic Bone Material Grafting and Without Grafting: A Randomized Clinical Trial Comparative Study

Implant Stability and Clinical Outcome between Implant Placement Using Internal Sinus Floor Elevation with Alloplastic Bone Material Grafting and Without Grafting: A Randomized Clinical Trial Comparative Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210517008
Enrollment
30
Registered
2021-05-17
Start date
2020-08-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteers who have lost a single upper premolar or molar tooth for 3 or more months with adequate bone width (6mm or more) and 5-8 mm of residual alveolar bone height Residual bone height 5 to 8 mm.

Interventions

Biphasic calcium phosphate is an alloplastic material which is composed of hydroxyapatite 30% and beta-calcium phosphate 70%. Using this material as a bone graft in the internal sinus floor elevation
Experimental Device,No Intervention Other
Biphasic calcium phosphate,non-biphasic calcium phosphate (non graft)

Sponsors

Center of Excellence for Dental Implantology, Faculty of Dentistry, Chiang Mai University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 68 Years

Inclusion criteria

Inclusion criteria: 1.Healthy volunteers ages, 20-68years 2.Single loss of premolar or molar in the posterior maxilla which is extracted at least 3 months with normal wound healing 3.A residual bone height of 5-8 mm with adequate bone width of 6 mm or above 4.Good intra-oral soft and hard tissue condition with adequate surrounding keratinized mucosa (at least 4 mm) from gingival margin of the tooth. 5.Good condition of the nearby and opposing tooth 6.No smoking or smoking less than 10 cigarettes/day in the last 5 years 7. Patient can clean and maintain the prosthesis and oral health regularly 8. No history of psychosis 9.No use of any medications that could influence bone remodeling including bisphosphonates and antiangiogenic drugs via intravenous injection in the past 5 years 10.Able and agree to undergo treatment and follow-up for a total of 12-14 visits 11.Understand research procedure with informed consent for participation in the clinical trial 12. No problem of temporomandibular joint disorder or any disease that will involve the quality of mastication

Exclusion criteria

Exclusion criteria: 1.Have Bleeding disorder, or uncontrolled systemic disease, ASA class III 2. Presence of bone pathologies such as cyst or tumor 3.Uncontrolled periodontal disease with a periodontal pocket of more than 4 mm in adjacent teeth and opposite tooth 4. Poor oral hygiene needs further treatment before implantation such as periodontal therapy 5.Have had radiotherapy to the head or neck 6.Drug or alcohol abuse such as steroid, antibiotics 7.Pregnant woman, nursing mother, or lactation 8.Acute/chronic paranasal sinusitis or rhinitis 9.previous bone graft or implant placement in the posterior maxilla 10.Demonstrate negative attitude towards implants and prosthesis 11.Unable to participate until the study is complete

Design outcomes

Primary

MeasureTime frame
implant stability immediate after implant placement or 3 months after placement and every 3 months until 1 years and 3 months after implantation. Resonance frequency analysis

Secondary

MeasureTime frame
success, survival or failure rate 6 months and 1 year after crown insertion mobility, bone loss in radiography, exudates history, pain, ability to stay in the patient's mouth,endo sinus bone gain and marginal bone loss immediate after implant placement or 3 months after placement and every 3 months until 1 years and 3 months after implantation. millimetre in radiography

Countries

Thailand

Contacts

Public ContactArpapat Sansupakorn

Faculty of Dentistry, Chiangmai University

zopia.nutchy@gmail.com0971714691

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026